Federal authorities have sent a warning letter telling a Seattle-based entrepreneur to stop all efforts to sell a purported coronavirus “vaccine’’ and remove any online claims that he can treat, cure or prevent COVID-19 symptoms.
The Food and Drug Administration sent the letter May 21 to Johnny Stine, 55, roughly three weeks after he made news for offering up his “nCov19 spike protein vaccine’’ for $400 on social media — including a pitch to his friend, the mayor of a San Juan Island town. Among the March and April postings referred to in the FDA letter was one on the personal Facebook page of Friday Harbor Mayor Farhad Ghatan offering to visit the island to administer the purported vaccine to him.
The FDA letter warns that vaccines claiming to cure or prevent illness require “well-controlled human clinical studies, substantiating that the claims are true at the time they are made. For COVID-19, no such study is currently known to exist for the product identified above. Thus, any coronavirus-related prevention claims regarding such product are not supported by competent and reliable scientific evidence. You must immediately cease making all such claims.’’
Stine, who could not be reached for comment, was warned in April by Washington state Attorney General Bob Ferguson to stop making such claims on his personal Facebook page and another belonging to his company, North Coast Biologics. Stine replied to Ferguson’s office soon thereafter that he would comply and told Facebook followers he could no longer sell the vaccine because “the state of Washington would rather you wait two years for your spike protein vaccine while your economy and most people’s lives fall apart in the meantime.’’
He went on to criticize FDA timelines for approving vaccines, adding: “Other countries, however, who accept science will be able to provide this vaccine to the masses soon as they aren’t interested in an FDA-like timeline. In times of a pandemic, the course of action to cower and wait two years is unacceptable and unethical when the solutions are right there under your face.’’
The FDA has said any COVID-19 vaccine is likely 12 to 18 months away.
In its warning to Stine, the agency acknowledged his stated intention to comply with Ferguson’s order, but added that his April 17 online exchange with Ghatan remained available online. It gave him 48 hours to take it down, or face a possible court injunction and seizure of his equipment and supplies.
The passages cited on Ghatan’s page have since been removed. Stine appears to have taken down his company Facebook page and limited access to his personal Facebook page.
Ghatan, 57, told The Seattle Times in an interview soon after Ferguson’s warning that he’d thought he was having a private conversation with Stine at the time and never meant for it to become public. He’d described Stine as a longtime friend and said he’d never intended to endorse his vaccine in any way.
The exchange drew the ire of several Friday Harbor residents, who felt Ghatan had endorsed an unlawful vaccine and also invited an outsider to their community during a period when travel to all San Juan Islands was heavily restricted due to pandemic fears. Ghatan issued a public apology for extending the invitation and said in his Times interview that he and Stine postponed their planned meetup to an indefinite future date.
But some of the island’s residents filed complaints with state and federal agencies, leading to the investigation of Stine and the warnings since delivered.